Effects of Ergometer Training With Telemonitoring in Patients With Chronic Obstructive Pulmonary Disease (COPD) After Exacerbation

NCT ID: NCT01987544

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-03-31

Brief Summary

Home ergometer training combined with online monitoring and regular telephone support could prove to be a cost-effective method to improve physical performance and quality of life in COPD patients.

The primary objective of the study is to demonstrate a significantly higher daily workout time in patients that are monitored during home ergometer training with telephone support compared to conventional home ergometer training. Consequently we expect an increased quality of life related to the illness and a decreasing BODE-Index. A post-interventional lower BODE-Index correlates with a reduced risk of hospitalisation and mortality.

Detailed Description

Hypothesis: There will be an increased prevalence, morbidity and mortality of COPD during the next decades. On the other hand there is a clear correlation between life expectancy and physical activity in this disease. Telemedicine concepts promise new treatment strategies with favourable impact on the long-term process of COPD.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-Control

3 months of ergometer training under self control at home without any interventional motivation.

Group Type: ACTIVE_COMPARATOR

Ergometer Training

Intervention Type: OTHER

Motivation

3 months of ergometer training at home with telemonitoring and motivation phone calls once a week when training sessions drop below 20 minutes per day.

Group Type: EXPERIMENTAL

Ergometer Training

Intervention Type: OTHER

Motivation

Intervention Type: OTHER

Interventions

Ergometer Training

Intervention Type: OTHER

Motivation

Intervention Type: OTHER

Other Intervention Names

Ergometer; Telemonitoring; Phone Calls

Eligibility Criteria

Inclusion Criteria

• COPD

Exclusion Criteria

• tumor diseases
• unstable coronary heart disease
• untreated cardiac valve disease
• incapable of giving consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitaphone GmbH

UNKNOWN

Sponsor Role: collaborator

Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role: lead

Responsible Party

Karl Josef Franke

Senior Physician Helios Klinik Hagen, Klinik für Pneumologie

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, Germany

Countries

Germany

References

Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

Reference Type: DERIVED

PMID: 33511633 (View on PubMed)

Other Identifiers

Telebike2013

Identifier Type: -

Identifier Source: org_study_id